K964929 is an FDA 510(k) clearance for the PERIPHERALLY INSERTED CENTRAL CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on June 2, 1997, 175 days after receiving the submission on December 9, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K964929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1996 |
| Decision Date | June 02, 1997 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |